Clinical Trial

Sequential Gemcitabine Plus Docetaxel Versus Gemcitabine Plus Mitomycin C for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer

Study acronym: GEMDOC-MMC
Recruiting Phase 2
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Summary
This prospective, randomized, open-label, phase II clinical trial compares two sequential intravesical chemotherapy regimens in patients with bacillus Calmette-Guérin (BCG)-unresponsive high-grade non-muscle-invasive bladder cancer (NMIBC) following complete transurethral resection of bladder tumor (TURBT). Participants are randomized in a 1:1 ratio to receive sequential intravesical gemcitabine plus docetaxel or sequential intravesical gemcitabine plus mitomycin C. The primary objective is to compare 12-month event-free survival between treatment groups. Secondary objectives include evaluation of cystectomy-free survival, progression-free survival, treatment safety, tolerability, and patient-reported quality of life.
Trial Details
NCT Number NCT07747740
Lead Sponsor Blokhin's Russian Cancer Research Center
Conditions Non-Muscle-Invasive Bladder Cancer, BCG-Unresponsive Bladder Cancer
Enrollment 228 participants
Start Date 2026-07-09
Primary Completion 2029-12-30 (estimated)
Study Completion 2030-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-05